Sobi
Global Director Medical Affairs(m/w/x)
VollzeitRemoteManagement
Basel
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SOSobi
Principal Medical Writer(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Strategic authoring of clinical and regulatory documents for rare disease therapies. 8-10 years regulatory medical writing experience leading global projects required. Professional conference attendance.
Anforderungen
- Life Science Master's degree or PhD
- 8-10 years' experience in regulatory medical writing
- Scientific and regulatory knowledge
- In-depth knowledge of regulatory medical writing processes
- Experience leading complex global regulatory/clinical writing projects
- Experience leading writing activities for major US/EMA regulatory submissions
- Coordination of Medical Writers and submission leadership
- Clear understanding of clinical development (phases, processes, techniques)
- Advanced knowledge of global regulatory environment/processes
- Excellent written and spoken English skills
- Highly developed analytical and strategic thinking
- Ability to identify key issues
- Clear and effective communication of complex ideas
- Strong interpersonal, communication, and influencing skills
- Ability to coordinate work of others
- Strong team player
- Ability to drive and manage team performance
- Effective collaboration with diverse backgrounds
- Result-orientation
- Excellent problem-solving skills
- Flexible attitude
- Ability to manage multiple parallel tasks
- Task prioritization under time pressure
- Highly developed respect for timelines
- Attention to detail
Aufgaben
- Provide communication expertise for clinical programs
- Lead strategic authoring of key clinical and regulatory documents
- Ensure clarity and consistency of clinical information
- Facilitate regulatory assessment processes
- Achieve commercially viable product labels
- Direct strategy for clinical regulatory submission components
- Ensure clear and compelling scientific content
- Align content with regulatory document objectives
- Prepare key clinical and regulatory documents
- Prepare documents for major regulatory submissions
- Prepare responses to regulatory agencies
- Provide leadership to cross-functional authoring teams
- Coordinate cross-functional authoring teams
- Ensure efficient delivery of clinical regulatory documents
- Ensure high quality of clinical regulatory documents
- Ensure regulatory compliance of clinical documents
- Liaise with senior project staff
- Develop storyboards for submissions
- Plan document development for prescribing information
- Provide strategic medical writing expertise
- Support multiple clinical development projects
- Ensure high technical quality of documents
- Ensure compliance with in-house technical requirements
- Coach less experienced Medical Writers
- Develop less experienced Medical Writers
- Oversee Medical Writers on your documents
- Coordinate Medical Writers on your documents
Berufserfahrung
- 8 - 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mehr Urlaubstage
- Generous time off
Weiterbildungsangebote
- Opportunity to attend conferences
Familienfreundlichkeit
- Work/life balance
Lockere Unternehmenskultur
- Collaborative and team-oriented environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sobi erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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SOSobi
Principal Medical Writer(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Strategic authoring of clinical and regulatory documents for rare disease therapies. 8-10 years regulatory medical writing experience leading global projects required. Professional conference attendance.
Anforderungen
- Life Science Master's degree or PhD
- 8-10 years' experience in regulatory medical writing
- Scientific and regulatory knowledge
- In-depth knowledge of regulatory medical writing processes
- Experience leading complex global regulatory/clinical writing projects
- Experience leading writing activities for major US/EMA regulatory submissions
- Coordination of Medical Writers and submission leadership
- Clear understanding of clinical development (phases, processes, techniques)
- Advanced knowledge of global regulatory environment/processes
- Excellent written and spoken English skills
- Highly developed analytical and strategic thinking
- Ability to identify key issues
- Clear and effective communication of complex ideas
- Strong interpersonal, communication, and influencing skills
- Ability to coordinate work of others
- Strong team player
- Ability to drive and manage team performance
- Effective collaboration with diverse backgrounds
- Result-orientation
- Excellent problem-solving skills
- Flexible attitude
- Ability to manage multiple parallel tasks
- Task prioritization under time pressure
- Highly developed respect for timelines
- Attention to detail
Aufgaben
- Provide communication expertise for clinical programs
- Lead strategic authoring of key clinical and regulatory documents
- Ensure clarity and consistency of clinical information
- Facilitate regulatory assessment processes
- Achieve commercially viable product labels
- Direct strategy for clinical regulatory submission components
- Ensure clear and compelling scientific content
- Align content with regulatory document objectives
- Prepare key clinical and regulatory documents
- Prepare documents for major regulatory submissions
- Prepare responses to regulatory agencies
- Provide leadership to cross-functional authoring teams
- Coordinate cross-functional authoring teams
- Ensure efficient delivery of clinical regulatory documents
- Ensure high quality of clinical regulatory documents
- Ensure regulatory compliance of clinical documents
- Liaise with senior project staff
- Develop storyboards for submissions
- Plan document development for prescribing information
- Provide strategic medical writing expertise
- Support multiple clinical development projects
- Ensure high technical quality of documents
- Ensure compliance with in-house technical requirements
- Coach less experienced Medical Writers
- Develop less experienced Medical Writers
- Oversee Medical Writers on your documents
- Coordinate Medical Writers on your documents
Berufserfahrung
- 8 - 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mehr Urlaubstage
- Generous time off
Weiterbildungsangebote
- Opportunity to attend conferences
Familienfreundlichkeit
- Work/life balance
Lockere Unternehmenskultur
- Collaborative and team-oriented environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sobi erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Sobi
Branche
Pharmaceuticals
Beschreibung
The company is a specialized biopharmaceutical company dedicated to rare diseases and committed to developing innovative therapies.
Noch nicht perfekt?
- Sobi
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